FDA product code MBD: Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
MBD is the FDA product code for prosthesis, knee, patello/femorotibial, unconstrained, uncemented, porous, coated, polymer/metal/polymer. It is a Class III device, reviewed by the Orthopedic panel. Devices under MBD reach the market by PMA; FDA lists no cleared 510(k)s for it. 2 PMA applications cite this product code. FDA has posted 1 recall for MBD devices.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer |
| Device class | Class III |
| Review panel | OR — Orthopedic |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for MBD devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2007-02-16.
Frequently asked questions
What is FDA product code MBD?
MBD is the FDA product code for prosthesis, knee, patello/femorotibial, unconstrained, uncemented, porous, coated, polymer/metal/polymer. It is a Class III device, reviewed by the Orthopedic panel.
What device class is MBD?
Class III. Typical premarket route: PMA.
Have MBD devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2007-02-16.
Next steps
- Run an FDA pathway report with predicate devices for product code MBD
- Run a recall and safety report across every MBD manufacturer
- Watch product code MBD for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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